A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:11/23/2013
Start Date:August 2012
End Date:February 2015
Contact:Andrew Coates
Email:andrew.coates@abbvie.com
Phone:847-938-1394

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A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)


The purpose of this study is to evaluate the safety and effect of co-administration of
ABT-450 with ritonavir (ABT-450/r) and ABT-267 in adults with chronic hepatitis C virus
infection.


Inclusion Criteria:

- Subjects must meet one of the following:

- Treatment-naive: Subject has never received antiviral treatment for hepatitis C
infection OR

- Treatment Experienced (Prior null responders, Partial responders or Relapsers to
pegIFN/RBV);

- Body mass index (BMI) is ≥ 18 to < 38 kg/m2.

- Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4
infection/without cirrhosis for at least 6 months prior to study screening.

- Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any drug.

- Females who are pregnant or breastfeeding.

- Recent history of drug or alcohol abuse that could preclude adherence to the
protocol.

- Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency
Virus (HIV) antibodies.
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